An Introduction to Pharmacovigilance

Dr Patrick Waller has been an independent consultant in pharmacovigilance and pharmacoepidemiology based in Southampton since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee. From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne. From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.

1: What is pharmacovigilance and how has it developed? . Origins and definition of pharmacovigilance. Scope and purposes. Development of pharmacovigilance since the 1960s. Conclusion . 2: Basic concepts . Introduction. Adverse Drug Reactions. The concept of safety. Causation - was the drug responsible?. Conclusion . 3: Types and sources of data . Introduction. Pre-clinical studies. Human volunteer studies. Clinical trials. Post-marketing surveillance. Conclusion . 4: The process of pharmacovigilance . Overview - a risk management process. Signal detection. Evaluation and investigation. Taking Action. Communication. Conclusion . 5: Regulatory aspects of pharmacovigilance . Introduction. Legislation and guidelines. Regulatory pharmacovigilance systems. Obligations of pharmaceutical companies. Conclusion . 6: International collaboration . Introduction. World Health Organisation. Council for the Organisation of Medical Sciences. International Conference on Harmonisation. Conclusion . 7: Ethical and societal considerations. Introduction. Stakeholders and their perspectives. Ethical principles. Ethical safeguards in relation to safety. Transparency. Conflicts of interest. Conclusion . 8: Future Directions . Introduction: current limitations. Meeting the challenges. Conclusion . 9: Learning more about pharmacovigilance . Books. Journals. Useful websites. Courses. International societies